Health TrialsbyHealthPanel

Emovi 3D Knee Assessment Device Intervention for Operational Readiness

ConditionsPatellofemoral PainPatellofemoral Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorWomack Army Medical Center

About this trial

This is a randomized clinical trial investigating the use of the Emovi Knee Kinesiography information in the treatment of anterior knee pain in physical therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-50

Active Duty Service Member stationed at Fort Liberty and Schofield Barracks

Diagnosis of patellofemoral pain (ICD-10 codes: M25.2 (pain in unspecified knee), M25.561 (pain in right knee), and M25.562 (pain in left knee)

Disqualifiers

Pregnancy

Known to be leaving that duty station within next 3 months

Concurrent lower limb injuries (examples include but are not limited to ankle sprain or HS strain)

Previous knee surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Emovi Knee Kinesiography

    Device

    All participants will receive a KneeKG exam. This device will capture three-dimensional knee kinematics for a participant's knee, using the KneeKG system. Therapists will use these reports and suggested exercises to guide their care for participants in the Intervention group.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Intervention: Knee KG informed physical therapyExperimental treatment 1 intervention
Group B: Control: Standard of care physical therapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function

PROMIS asks patients about their functional ability, and symptoms. This tool is designed as a health-focused rather than a disease-focused measurement system. The primary outcome measure will focus on the the Physical Function domains since PFPS is known to limit function during daily and sports \& recreation activities. This is an adaptive questionnaire that is taken in RedCap and contains up to 166 questions that will not all be asked, scored 1-5 on a Likert scale based on limits of function. The primary outcome is the between-group difference in PROMIS Physical Function T-score at 3 months. A linear mixed effects model will be used to analyze the between-group differences across the various time points (repeated measures).

Time frame
12 weeks

Secondary outcomes

1

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

This PROMIS tool focuses on pain interference in daily life. This questionnaire is adaptive taken in RedCap and contains up to 41 questions that will not all be asked. It is scored on a 5 point Likert scale based on limitation due to pain.

Time frame
12 weeks
2

Anterior Knee Pain Scale (AKPS)

The Anterior Knee Pain Scale is a 13-item more specific questionnaire related to PF pain which will allow to assess pain and symptoms during specific loading-activities. The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points. Athletes would receive a score of 100 if they showed no signs of anterior knee pain.

Time frame
12 weeks
3

Self-Reported Readiness to Return to Duty

The Self-Reported Readiness to Return to Duty questionnaire consists of three questions to assess perceived readiness to return to duty

Time frame
12 weeks
4

Total Lost Duty Days

Tracking the amount of duty days a soldier missed while enrolled in protocol.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Womack Army Medical Center

Lead sponsor

The Geneva Foundation

Collaborator

Source ClinicalTrials.gov
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